Event
Course Description:Learn about parameters for validating analytical procedures for small molecules based on USP−NF General Chapters <1225> Validation of Compendial Procedures and <1226> Verification of Compendial Procedures. Topics include comparing <1225> and <1226> and understanding the differences between <1225> and ICH guidelines. Elements on Method transfer and the complementary chapter USP−NF <1210> Statistical Tools for Procedure Validation will also be discussed in this course.
Upon completion of this course, you will be able to:
- Understand how approaches to validation depend on the intended application of the procedure
- Learn when each is appropriate - validate versus verify
- Evaluate the characteristics to consider for validation of various analytical procedures
- Gain an understanding of the design of validation experiments and interpretation of results
- Understand how to review techniques to minimize resources required
- Gain an understanding of the different approaches for transfer of procedures
- Understand the differences and the relationship between validation, verification and transfer of analytical procedures
- Identify methods and statistical tools used for procedure validation
Who Should Participate:
- Analytical chemists
- QA/QC
- R&D
- Project management
- Manufacturing Staff
- CROs
- Regulatory professionals
- Technical liaison, who are involved in the validation and verification of analytical procedures.
NOTE: You must have at least 2 years experience in pharmaceutical industry to get the full benefit of this course.